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Understanding outcomes in patients with alopecia areata treated with ritlecitinib

PRESTO - Characterization and Clinical Outcomes of Alopecia Aerata (AA) Patients Treated With Ritlecitinib in a Real-world (RW) Cohort: A Multinational, Prospective Observational Study.

Observational Pfizer · NCT06531109

This study looks at how well the medication ritlecitinib works for people with alopecia areata and what effects it has on their condition.

Quick facts

Study typeObservational
Enrollment850 (estimated)
Ages12 Years and up
SexAll
SponsorPfizer Industry-sponsored
Drugs / interventionsritlecitinib
Locations58 sites (Montgomery, Alabama and 57 other locations)
Trial IDNCT06531109 on ClinicalTrials.gov

What this trial studies

This observational study focuses on patients diagnosed with alopecia areata who are being treated with ritlecitinib, a medication that targets specific pathways involved in the disease. The study aims to characterize the clinical outcomes of these patients, including the effectiveness and safety of the treatment. Participants will be monitored for their response to the medication, with data collected on various factors such as age, disease severity, and treatment duration. The findings will help inform treatment practices and improve understanding of alopecia areata management.

Who should consider this trial

Good fit: Ideal candidates for this study are males and females aged over 12 years with a confirmed diagnosis of alopecia areata who are prescribed ritlecitinib.

Not a fit: Patients who do not have alopecia areata or those who are not prescribed ritlecitinib will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the effectiveness of ritlecitinib for treating alopecia areata, potentially leading to improved treatment strategies.

How similar studies have performed: Other studies have shown promising results with JAK inhibitors in treating alopecia areata, indicating that this approach has potential based on previous findings.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Male and female patients aged \>12 years at baseline.
2. Patients with diagnosis of alopecia areata confirmed by a certified dermatologist, who are prescribed ritlecitinib as per the product label independently of the decision to enroll a patient in this study.
3. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study. Following receipt of oral and written information about the trial, the adolescent (depending on local institutional review board/independent ethics committee requirements) must provide assent, and one or both (according to local regulations) parents or guardians of the child must provide signed informed consent before any study-related activity is carried out.
4. Patients, who in the opinion of the investigator, are willing and able to comply with regular clinic visits as per standard practice at the site and agree to complete PRO questionnaires and other patient completed questions.

Exclusion Criteria:

1. Diagnosed with other types of alopecia or other diseases that can cause hair loss (including, but not limited to known androgenetic alopecia, traction and scarring alopecia, telogen effluvium).
2. Diagnosed with other scalp diseases that may impact AA assessment (e.g., scalp psoriasis, dermatitis, etc.) or other active systemic diseases that may cause hair loss (e.g., lupus erythematosus, thyroiditis, systemic sclerosis, lichen planus, etc.). that could interfere with assessment of hair loss/regrowth.
3. Patients previously treated with ritlecitinib or other JAK inhibitors.
4. Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family.

Where this trial is running

Montgomery, Alabama and 57 other locations

+8 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Alopecia Areata
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.